Celltrion has again submitted a biologics license application (BLA) for its biosimilar version of Roche and Biogen’s Rituxan (rituximab) to the US Food and Drug Administration (FDA).
The Korean firm’s candidate – CT-P10 (rituximab) – received EU regulatory approval in February last year to treat patients with some autoimmune diseases and cancers.
Celltrion also has announced plans to resubmit its biosimilar version of Roche’s Herceptin (trastuzamab) to the FDA in June. CT-P6 (trastuzumab) – approved in the EU in March – is a monoclonal antibody (mAb) biosimilar candidate designed to treat HER2-positive breast and gastric cancers.
The company requested US regulatory approval for CT-P10 in April 2017 and for CT-P6 in May 2017, but last month Celltrion announced both had been rejected.
The Agency vetoed the monoclonal antibody candidates in complete response letters (CRLs) related to an FDA warning letter regarding Celltrion’s manufacturing facility in Incheon, South Korea.
In a statement released earlier today, Celltrion said it had “made progress addressing the concerns” raised in the FDA’s warning letter and is “confident” that both biosimilar candidates will become alternative oncology treatment options in the US.
The firm expects both biosimilar candidates to receive US approval this year. According to the terms of a 2016 deal with Teva Pharmaceutical Industries, the Israeli drugmaker has the right to commercialise both biosimilars – pending approval – in North America.
Pfizer’s proposed biosimilar version of Herceptin – PF-05280014 – was also rejected by the FDA this year. Earlier this month, the Agency issued a CRL in response to Pfizer’s BLA, which the big pharma company said did not relate to safety or clinical data concerns.